# FDA 483 - Invitrx Therapeutics Inc. - April 30, 2025

Source: https://www.keypedia.com/records/483/invitrx-therapeutics-inc/3ca43965-bfd4-49b0-b6bb-1db069f3a7cd

> FDA 483 for Invitrx Therapeutics Inc. on April 30, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Invitrx Therapeutics Inc.
- Inspection Date: 2025-04-30
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Invitrx Therapeutics Inc. in Lake Forest, CA, revealed significant deficiencies in their manufacturing of human blood HCT/Ps. The firm failed to establish and follow critical procedures for donor eligibility, product release, manufacturing controls, and quality programs. These issues indicate a high risk of releasing unsafe or non-compliant products due to inadequate controls, record-keeping, and equipment maintenance.

## Related Documents

- [WARNING_LETTER - 2019-04-03](https://www.keypedia.com/records/warning_letter/invitrx-therapeutics-inc/609c196c-c4a1-4fb7-80a4-7aff1231849d)
- [483 - 2022-03-22](https://www.keypedia.com/records/483/invitrx-therapeutics-inc/f2c132a4-92b9-498a-ad13-42a0d14479e9)
- [483 - 2025-04-30](https://www.keypedia.com/records/483/invitrx-therapeutics-inc/8e20c736-81a1-4164-ad17-4d5883461c2d)

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)
- [Laurissa S. Flowers](https://www.keypedia.com/people/laurissa-s-flowers/27453525-c2fc-4a05-9cdc-7a1ed884304f)

Company: https://www.keypedia.com/companies/invitrx-therapeutics-inc/56153bdd-2935-4184-99ff-28af39f1fc61

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6